Late PCI Holds No Benefit Over Medical Therapy for Quality of Life

Action Points

Explain to interested patients that percutaneous coronary intervention more than three days after myocardial infarction held a small advantage over medical therapy alone at four months, but that difference faded within a year.

Explain that the few advantages of late PCI were insufficient to make it economically attractive.

Note that the data came from a subgroup analysis of the Occluded Artery Trial, which found PCI to be no more effective than medical therapy alone after four years.

At four months, patients who had PCI more than three days after MI had better measures of cardiac functioning than those who had medical therapy alone, but the differences faded within a year, Daniel B. Mark, M.D., of Duke University Medical Center, and colleagues reported in the Feb. 19 issue of the New England Journal of Medicine.

And a cost-benefit analysis revealed that the few advantages of the procedure were insufficient to make it economically attractive, the researchers said.

"Medical therapy alone resulted in both lower cumulative medical costs and higher quality-adjusted life expectancy at two years," the researchers said

The conclusions came from a subgroup analysis of the Occluded Artery Trial (OAT), a test of the open-artery hypothesis, which postulated that late opening of occluded infarct-related arteries after heart attack may improve survival, ventricular function, and quality of life.

For the present study, the researchers assessed a subgroup of 951 patients, analyzing quality of life and economic outcomes.

Quality of life was assessed by the Duke Activity Status Index (DASI), which measures cardiac physical function on a scale from 0 to 58 with higher scores indicating better function and by the Medical Outcomes Study Short-Form Mental Health Inventory 5 (MHI-5), which measures psychological well-being.

Quality-of-life interviews were performed at four, 12, and 24 months, and cost-effectiveness was assessed for 458 of the patients for whom medical billing data were available.

At four months, the medical therapy group had a decrease of 3.4 points in DASI scores compared with the PCI group (P=0.008), but the differences were smaller and nonsignificant after a year.

The mean between-group difference in DASI scores was 1.0 at 12 months and 1.7 at 24 months (P=0.36 and P=0.29, respectively).

There were no significant differences in psychological well-being, the researchers said.

For the 458 patients for whom medical billing information was available, two-year costs were about $7,000 higher in the PCI group (P<0.001).

Quality-adjusted two-year survival was marginally longer in the medical therapy group, at 1.45 years compared with 1.42 years in the PCI group.

"The small benefits observed with regard to symptoms were insufficient to make PCI an economically attractive strategy for patients," the researchers said.

They acknowledged that the study was limited because it was smaller than initially planned and because treatment was not blinded.

Still, they concluded that "combined with the previously reported lack of advantage of PCI with respect to the primary endpoint of the OAT, these data do not provide support for the common practice of routine PCI in patients in stable condition after myocardial infarction with an occluded infarct-related artery."

Mark Turco, M.D., of Washington Adventist Hospital in Takoma Park, Md., and a trustee of the Society for Cardiovascular Angiography and Interventions, emphasized that the OAT trial was performed in a selective, low-risk patient population.

"These are patients who, on average, presented eight days into their onset of symptoms, had single vessel disease, and were at lower risk than we normally see in MI patients," said Dr. Turco.

Other findings, particularly those of the BRAVE 2 trial. published in the Journal of the American Medical Association in 2005, have shown a "clear mortality advantage" for late PCI in high-risk patients, he said, adding that less healthy patients are good candidates for late PCI.

The study was funded by a grant from the National Heart, Lung, and Blood Institute.

Eli Lilly donated replacement doses of abciximab (ReoPro) and funding for meetings (in 2001, 2002, and 2006). Guidant donated stent reimbursement for one site and stents for OAT sites. Medtronic (Canada) donated stents for the Canadian sites. Merck donated funding for training meetings.

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